Dietary approach to managing mild-to-moderate psoriasis

The Role of Gut-skin Axis in Psoriasis: a Randomized Placebo-controlled Dietary Approach to Assess Clinical Efficacy in Mild-to-moderate Psoriasis

This study tests if changing the diet, especially by looking at gluten sensitivity, can help people with mild-to-moderate psoriasis feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Palermo (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Palermo, Palermo and 2 other locations)
• Trial ID: NCT05644782 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of dietary interventions, specifically focusing on gluten sensitivity, in patients with mild-to-moderate psoriasis. It aims to explore the gut-skin axis and how dietary changes may influence the inflammatory processes associated with psoriasis. Participants will undergo an open wheat challenge and a placebo challenge to assess their reactions and symptoms. The study seeks to understand the potential link between diet and psoriasis severity, particularly in patients who may have gluten sensitivity.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with mild-to-moderate psoriasis who have not undergone systemic therapy for at least three months and do not have gluten sensitivity.

Not a fit: Patients with severe chronic plaque-type psoriasis, those who have self-excluded gluten from their diet, or individuals with other significant gastrointestinal or inflammatory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a dietary management option for patients with psoriasis, potentially reducing symptoms and improving quality of life.

How similar studies have performed: While dietary approaches in managing psoriasis are being explored, this specific focus on gluten sensitivity and its direct impact on psoriasis is relatively novel and has not been extensively tested in previous studies.

Eligibility criteria

Inclusion criteria of psoriasis patients

* age \>18 and \<65 years;
* no systemic therapy for psoriasis for at least 3 months before inclusion in the study;
* negativity of anti-deamidated gliadin protein (anti-DGP) immunoglobulins (Ig) class A (IgA) and immunoglobulins (Ig)G, anti-tissue transglutaminase (anti-tTG) class IgA and IgG, and Endomysium antibodies (EmA);
* absence of WA (negative prick-test and/or specific serum immunoglobulins (Ig)E assay for wheat, gluten, and gliadin).

Exclusion criteria of psoriasis patients age \<18 and \>65 years;

* severe chronic plaque-type psoriasis (based on BSA);
* self-exclusion of gluten/wheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;
* pregnancy;
* alcohol and/or drug abuse;
* Helicobacter pylori and other bacterial and/or parasitic infections;
* diagnosis of chronic inflammatory bowel disease and other organic pathology affecting the digestive system (e.g., severe liver disease), nervous system diseases, major psychiatric disorders, immunological deficits, and impairments that limit physical activity;
* diagnosis of cancer
* treatment with steroids and/or immunological therapies;
* patients undergoing chemotherapy and/or radiotherapy.

Where this trial is running

Palermo, Palermo and 2 other locations

• Dermatology Department of the University Hospital 'P. Giaccone' of Palermo, Italy, — Palermo, Palermo, Italy (Recruiting)
• Internal Medicine Department of the University Hospital of Palermo — Palermo, Palermo, Italy (Recruiting)
• Internal Medicine Division of the "Cervello-Villa Sofia" Hospital — Palermo, PA, Italy (Recruiting)

Study contacts

• Study coordinator: Pasquale Mansueto, MD

Conditions Psoriasis; Gluten Sensitivity; psoriasis; gluten sensitivity; gluten-free diet